Safety and Performance of the Omnipod® Hybrid Closed-Loop System in Children Aged 6-12 Years with Type 1 Diabetes over Five Days Under Free-Living Conditions

The safety and performance of the Omnipod® hybrid closed-loop (HCL) personalized model predictive control algorithm was assessed in children with type 1 diabetes (T1D) using an investigational device over 5 days in a supervised hotel setting under free-living conditions. Eligible participants were aged 6-11.9 y with A1C Disclosure J. Sherr: Consultant; Self; Medtronic MiniMed, Inc.. Advisory Panel; Self; Insulet Corporation, Eli Lilly and Company, Bigfoot Biomedical. G.P. Forlenza: Advisory Panel; Self; Dexcom, Inc.. Research Support; Self; Medtronic, Tandem Diabetes Care, Inc., Insulet Corporation, Dexcom, Inc., Novo Nordisk Inc., Bigfoot Biomedical. B. Buckingham: Advisory Panel; Self; Novo Nordisk Inc., ConvaTec Inc.. Research Support; Self; Medtronic, Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc.. Consultant; Self; Tandem Diabetes Care, Inc., Becton, Dickinson and Company. T.A. Peyser: Consultant; Self; Insulet Corporation, Dexcom, Inc.. Employee; Self; ModeAGC. Consultant; Self; Biolinq. J. Lee: Employee; Self; Insulet Corporation. J.B. OConnor: None. B. Dumais: Employee; Self; Insulet Corporation. L.M. Huyett: Employee; Self; Insulet Corporation. J.E. Layne: Employee; Self; Insulet Corporation. T.T. Ly: Employee; Self; Insulet Corporation.